Drug/Device and Device/Drug Combinations in the EU and USA (London, United Kingdom - October 18-19, 2018)

  • ID: 4435604
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: October 18-19, 2018
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Practical Guidance on Borderline Issues and Combination Products

The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating a medicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.

PRE-SEMINAR READING It is recommended that you have read the Medical Device Directives and the Essential Requirements Annex 1 & 3 prior to attending this seminar

Why you should attend:

  • Understand the European Regulatory Guidance
  • Know what your Competent Authority expects
  • Gain an insight into Notified Bodies considerations on drug/device products
  • Learn how to define the approval route for your product
  • Clarify the major differences in documentation and approval routes
  • Consider quality systems requirements for combination products
  • Discover the FDAs Regulatory approach to combination products
  • Hear how to deal with Human Tissue Engineered products
  • Stay up-to-date on Post Market Surveillance for combinations products.

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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Day one

09.30  Chairman’s welcome
Dr David Jefferys

09.40   Introductory overview
- Background
- Life cycle management
- Exclusivity
- Patents
Dr David Jefferys

10.10  European regulatory guidance
- Life expectations of a competent authority
- Impact of the revision to the MDD
- EMEAs viewpoint management
Dr Elizabeth Baker

11.00  Refreshments

11.20  European regulatory guidance - (continued)
Dr Elizabeth Baker

12.30   Panel discussion on the EU regulatory requirements

12.45      Lunch

13.45     Defining the regulatory approval route    for your product
- Product classification
- Differences between device containing ancillary medicinal substances and medicinal products
Theresa Jeary

14.30     Medical Device CE Certification - Notified      Body expectations
- Devices containing ancillary medicinal substance
- Devices containing ancillary human blood derivative
- Post CE Marking expectations and changes
Theresa Jeary

15.15  Discussion

15.30     Refreshments

15.45  Highlights of major differences in documentation between:
- Device
- Drug and device
- Device and drug
Theresa Jeary

16.15   Quality and non-clinical considerations for combination products
- Quality, pre-clinical and biocompatibility issues and    how to address these for combination products
- What kind of non-conformance can we expect if     you combine a drug and device?
Theresa Jeary

16.45    Discussion

17.00    End of day one

Day two

09.00       Review of day one
Dr David Jefferys

09.05    Companion diagnostics
Dr David Jefferys

09.30    Clinical trial considerations
Dr David Jefferys

10.15 FDA’s approach to combination products
- FDA’s approach to combination products
- Requirements for product assignment, pre-market review and post-market regulation
- Good Manufacturing Practice (GMP) regulation
- Resources and guidance documents
- Hints and tips on good approaches
Mark Kramer

11.00    Discussion

11.10    Refreshments

11.20    FDA’s approach to combination products - (continued) Mark Kramer

12.45    Panel discussion Compare and contrast EU and USA regulations

13.15       Lunch

14.15     Human tissue engineered products
- What are tissue engineered and advanced      therapy combination medicinal products?
- How are these new borderline products regulated      in the EU and US?
- What are the practical challenges with       development of these products?
- Impact of the proposed regulation on medical      devices
Alison Wilson

15.00    Discussion

15.10       Refreshments

15.30    Post market surveillance for combination       products: Vigilance or pharmacovigilance?
Dr David Jefferys

16.15    Discussion

16.45    Close of forum

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  • David Jeffreys Mr David Jeffreys,
    Senior Vice President ,

    Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine he worked in clinical and academic medicine, before spending 20 years as a senior regulator for both medicines and medical devices. He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.

  • Mark Kramer Mr Mark Kramer,
    President ,
    Regulatory Strategies, Inc.

    Dr Mark Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products. He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, he was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs for the medical device business.

    He is on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.

  • Elizabeth Baker Ms Elizabeth Baker,
    Group Manager ,

    Dr Elizabeth Baker is Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA. The unit has responsibility for advising on the drug/device borderline, advising on regulatory aspects of drug/device combinations, and undertaking the assessment of data on the medicinal aspects of these combinations on which the MHRA is consulted by Notified Bodies. She has been involved in all stages of the assessment of abridged, new drug and variation applications for medicinal products particularly those in the ophthalmic, dental, surgical and contact lens care categories. Prior to joining the MHRA she was at Pfizer Central Research from 1979.

  • Alison Wilson Ms Alison Wilson,
    CellData Service ,
    Principal Consultant

    Alison Wilson is an Independent Regulatory Affairs Consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 – Tissue Engineered Medical Products and a member of BSI Technical Panel RGM/1 – Regenerative Medicine.

    Alison is a Module Advisor for the TOPRA* MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.

    She is now Principal Consultant at CellData Service who provide strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies and drug-device combination products in the EU. She has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.

  • Theresa Jeary Ms Theresa Jeary,
    Technical Manager for Medical Devices ,
    Lloyds Register Quality Assurance (LRQA)

    Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.

    Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been a part of the team for many commercially available medicinal and medical device products.

    Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

    Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).

    Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.

    At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.

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Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who are interested in medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.

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The Cavendish Hotel
81 Jermyn Street
United Kingdom

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